FDA Regulation 2017- 3D Printing and Medical Devices
Instructor : Rachelle D'Souza
Aug 25, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes
3D printing is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete. It is a type of additive manufacturing of objects which are produced from a digital 3D file, such as a computer-aided design (CAD) drawing or a Magnetic Resonance Image (MRI).
This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices.
Why Should You Attend:
The Food and Drug Administration (FDA) is responsible for the approval of medical devices in the United States of America. Today 3D printing is used in a wide variety of applications, even for the manufacture of medical devices. So, what are FDA’s current thoughts regarding the approval of 3D printed medical devices?
In this session, medical device manufacturers, software developers, engineers, validation experts, 3D printing raw material manufacturers and suppliers, regulatory and quality professionals, will be informed of FDA’s expectations regarding the design, manufacture and testing of 3D printed medical devices. Those interested in 3D printing technology will be well briefed too.
Areas Covered in the Webinar:
- An Introduction to 3D Printing.
- Its applications, terminology, advantages and challenges
- An Introduction to Medical Devices & Overview of Medical Device Regulation in USA.
- Classes and types of medical device
- 3D Printing of Medical Devices & FDA’s current thoughts.
- Manufacture and testing considerations for approval
Who Will Benefit:
The following professionals from the Medical Device industry will benefit from this training:
- Product management
- Research and Development
- Software developers and vendors
- Validation experts
- 3D printing raw material manufacturers and suppliers
- Regulatory and quality professionals
- Anyone interested in 3D printing technology and / or medical devices